specialty drugs in workers’ compensation update...2017, specialty drugs accounted for 5.8% of...

SPECIALTY DRUGS IN WORKERS’

COMPENSATION UPDATEA POPULATION-BASED ASSESSMENT (2020 UPDATE)

Executive Summary 3-4

Inflammatory Conditions — DMARDs14-17

Venous Thromboembolism — Anticoagulants 6-7

HIV — Antiretrovirals8-11

Introduction5

Hepatitis C — Antivirals 12-13

Osteoarthritis — Viscosupplementation18-19

Chemotherapeutic Agents 23-25

References32 - 33

Appendices A — Specialty Medications29 - 30

Appendices B — Pipeline31

About myMatrixx — Acknowledgement 28

Conclusion 27

Risk of Noncompliance 26

Botox®20

Alternative Migraine Treatments21-22

TABLE OF CONTENTS

AUTHORS: Michael Nguyen, PharmD

Eljana Angjellari, PharmD

Phil Walls, RPh

2

EXECUTIVE SUMMARY Specialty drugs are typically newer, complex, high-value medications that are rapidly becoming standard treatment

for many rare and chronic conditions.1 According to Information Medical Statistics (IMS) Health, United States

specialty net spending rose from 24.7% in 2008 to 46.5% in 2017. Specialty medicines are rapidly approaching half

of total drug spend. Across all settings, specialty medicines treat relatively few patients and have costs far higher per

patient than traditional medicines.2

IN THIS WHITE PAPER, MYMATRIXX WILL IDENTIFY AT LEAST SEVEN SIGNIFICANT PATIENT POPULATIONS WHERE SPECIALTY DRUGS ARE THE TREATMENT OF CHOICE:

Injured workers who have undergone orthopedic surgery

1Workers who may have been exposed to HIV through needle-stick injury or other means

2Workers who have been exposed to hepatitis C virus through blood or other infectious bodily fluids

3

Patients who have symptoms of rheumatoid arthritis or ankylosing spondylitis

4Injured workers who experience migraine, limb spasticity, cervical dystonia and bladder overactivity due to traumatic brain injury or spinal cord injury

6Workers whose osteoarthritis pain has been exacerbated by their job

5

Workers who develop cancer from occupational exposure in states with cancer presumption laws

73

Specialty medicines are rapidly approaching

half of total drug spend.

Along with these medications being so costly, these treatments also require enhanced clinical

monitoring and medication management to ensure successful outcomes. The role of the Pharmacy

Benefits Manager (PBM), as it pertains to the growing field of specialty medications, is to provide

comprehensive utilization and patient management. Additionally, myMatrixx works closely with our

network specialty pharmacies to ensure that patients receive the highest level of patient care in

order to gain full therapeutic advantage for these complex conditions. Lastly, through myMatrixx’s

partner specialty pharmacy, Accredo®, some conditions qualify for outcome guarantees.

continued Executive Summary

4

INTRODUCTIONSPECIALTY DRUGS ARE HIGH-COST PRESCRIPTION DRUGS USED TO TREAT COMPLEX, RARE, CHRONIC CONDITIONS, AND MOST SPECIALTY DRUGS REQUIRE PRESCRIBING FROM A SPECIALIZED PHYSICIAN.

The distribution of drug spend has shifted strongly to

specialty medicines from traditional therapy. These drugs

cost four times as much as other traditional prescription

medications for payers. According to the 2018 Drug

Trend Report provided by myMatrixx, payers spent an

average of $5,130.57 per injured worker on specialty

medications. It also found that spending on specialty

medications increased by 18.5% for payers in 2018. In

2017, specialty drugs accounted for 5.8% of total drug

spending, which increased to 7.1% in 2018. Although

only 1.7% of injured workers use specialty drugs, they

contribute to 7.1% of costs spent on all medications

prescribed to injured workers.

The financial impact can be significant for payers,

making it a critical priority to closely monitor utilization

and effectively administer cost containment strategies

for specialty medications.

Our partner specialty pharmacy, Accredo®, provides

individualized care to the needs of patients by

connecting them with specialized pharmacists, nurses

and other pharmacy experts who have extensive

training and experience in specific disease states and

specialty medications. Specialists are available for

patient counseling at all times. Accredo guarantees

the compliance of injured workers infected with

Hepatitis C (HCV) by providing full medication cost

if the initial trial of antivirals proves to be ineffective

after initiation and completion of the first treatment

through their specialty pharmacy.

The most common conditions that necessitate

specialty drug coverage across workers’ compensation

patient population include Venous Thromboembolism

prophylaxis, HIV, hepatitis C, inflammatory conditions,

chronic migraines and cancer. This paper reviews

specialty drug trends and provides insights utilizing

current treatment guidelines.

Costs more than $600 per month

Treats a rare condition

Requires special handling

Uses a limited or restricted distribution network

Requires enhanced clinical montoring

THE AMERICAN JOURNAL OF MANAGED CARE (AJMC) DEFINES

A SPECIALTY DRUG AS HAVING FIVE KEY COMPONENTS:

1

2

3

4

5

5

Additionally, when comparing DOACs to the specialty

injectable anticoagulants, they provide a significant

cost savings. Prophylactic anticoagulation therapy may

range from 12 to 42 days post surgery, depending

on the type of surgery and bleeding risk factors.6 The

following tables provide a cost analysis comparing 30-day

regimens. Although generic Lovenox®, enoxaparin, is FDA

approved and available on the market, the cost may vary

significantly per manufacturer.

The anticoagulation prescribing patterns from

myMatrixx prescribers have consistently shifted with the

recommended guidelines. In 2018, Eliquis prescriptions

accounted for 36% of total anticoagulant transactions,

followed by Xarelto (21.8%), Pradaxa (9.73%) and Lovenox

(1.98%). Currently the DOACs do not have generics

available on the market. However, the patents are set to

expire for Pradaxa in 2021, Xarelto in 2024, and Eliquis in

2031.7,8,9

Adherence and timely access to anticoagulation therapy

significantly reduces the risk of complications from

blood clots and therapy cost. According to the CDC,

blood clots cost our nation up to $10 billion each year.

Treatment can be as much as $15,000 to $20,000 per

person and often results in readmission to the hospital.10

Standard anticoagulation treatment to prevent blood

clots post-surgery is strongly recommended per the Chest

Guidelines.

Lovenox® (enoxaparin), Fragmin® (dalteparin) and Arixtra®

(fondaparinux) are specialty injectable anticoagulants

used to prevent blot clots. The immobility of an injured

worker post orthopedic surgery increases the risk for

blood clot formation in the veins known as venous

thromboembolism (VTE). Deep vein thrombosis (DVT)

occurs when blood clots form in the deep veins,

commonly post knee or hip surgery. DVT may break off

and travel through the veins and to the lungs, which

results in pulmonary embolisms (PE). DVT and PE are

forms of VTE.

The incidence of asymptomatic DVT after a major

orthopedic surgery ranges from 40% to 60%, whereas

the incidence of symptomatic DVT ranges from 0.5% to

4%.3 Estimates indicate that 40% to 50% of untreated

symptomatic DVT patients will develop a PE within

3 months, and 10% of untreated symptomatic PE

patients will die within 1 hour of onset.4 For these

reasons, guidelines recommend standard prophylactic

anticoagulation therapy post orthopedic surgery.

The specialty injectable anticoagulants and Coumadin®

(warfarin) have been the gold standard for VTE

prophylaxis and treatment for decades. However, now the

American College of Chest Physicians (CHEST) guidelines

recommend direct oral anticoagulants (DOACs) such as

Eliquis® (apixaban), Pradaxa® (dabigatran) and Xarelto®

(rivaroxaban) as first line therapy.5 The benefit of these

novel oral anticoagulants is that they do not require

enhanced clinical monitoring. Therefore, they are not

considered specialty medications.

VENOUS THROMBOEMBOLISMANTICOAGULANTS

6

Table 1

Table 2

Direct Oral Anticoagulants Cost of RegimenRegimen

Eliquis® (apixaban)

Xarelto® (rivaroxaban)

Pradaxa® (dabigatran)

2.5 mg once daily

10 mg once daily

220 mg once daily

$533

$537.59

$519.14

Specialty Injectable Anticoagulants Cost of RegimenRegimen

Lovenox® (enoxaparin)

Arixtra® (Fondaparinux)

Fragmin® (dalteparin)

40 mg once daily

2.5 mg once daily

5,000 units daily

$285.84 - $1,070.46

$1,731

$1,477.50

VENOUS THROMBOEMBOLISMANTICOAGULANTS

7

HIVANTIRETROVIRALS

Antiretroviral medications used to manage human immunodeficiency virus (HIV) infections

are a group of specialty medications used in workers’ compensation mainly for post-exposure

prophylaxis (PEP). Post-exposure prophylaxis involves taking a short course of antiretroviral

medications after a potential occupational exposure to HIV to prevent infection. This approach has

been largely accepted as reasonable and necessary. Because of the severe ramifications of an actual

infection, PEP is routinely utilized when a work-injury presents the employee with the risk of HIV

infection, although data show that the risk of infection is relatively low among healthcare workers.

Healthcare workers who have either been exposed to a needle stick involving HIV infected blood

at work, have had percutaneous exposure or mucous membrane exposure have a 0.23%, 0.3% and

0.09 % risk infection, respectively.11,12

The most current guidelines for treating occupational exposure to HIV are provided by the

US Public Health Service (PHS), which was published in 2013. Previous guidance regarding

occupational PEP was provided by the Centers for Disease Control and Prevention (CDC) in 2001.

The CDC used to recommend PEP therapy based on the severity of exposure (e.g., a two-drug

regimen for less severe exposures and three-drug regimens for more severe exposures). The

PHS now recommends a regimen of three drugs to be used routinely. The PHS guidelines also

specifically recommend Truvada® and Isentress® as the preferred regimen.

Consistent with these guidelines, myMatrixx providers have been prescribing Truvada® once daily,

which is a combination agent containing two drugs (tenofovir 300 mg and emtricitabine 200 mg)

and Isentress® (raltegravir 400 mg) twice daily. Some providers, however, are substituting Tivicay®

for Isentress®. Tivicay® is in the same drug class as Isentress®, but only needs to be taken once daily.

The difference in cost between the two alternative regimens is approximately $200:al

Table 3

Total Cost of PEP course

Most common regimen

Alternative regimen

Truvada® once daily ($2,109.48) +Isentress® 400 mg twice daily ($1,889.28

Truvada® once daily ($2,109.48) +Tivicay® 50 mg once daily ($2,088.59)

$3,998.76

$4,198.07

8

Deviations from the above regimens are rare, but necessary in certain circumstances such as drug interactions (i.e.,

the exposed patient is taking a medication that interacts with the PEP medications) or other contraindications.

Additionally, if the HIV infected person is taking a particular treatment regimen, the exposed person may need to

take the same regimen for PEP.

It is plain to see that the decision to use a two-drug or three-drug regimen for PEP presents a significant difference

in cost. Although the PHS guidelines will likely drive providers toward using a three-drug regimen routinely, it may

still be appropriate to use a two-drug regimen in which Truvada® is the likely drug of choice. According to the

PHS, the use of a two-drug regimen for PEP may still be appropriate because, “the optimal number of medications

needed for HIV PEP remains unknown”, and “no new definitive data exist to demonstrate increased efficacy

of three-drug HIV PEP regimens compared with the previously recommended two-drug HIV PEP regimens for

occupational HIV exposures associated with a lower level of transmission risk.”13 For these reasons, claims handlers

may see prescriptions for only Truvada® from time to time for PEP. Common side effects of PEP therapy includes

nausea and vomiting, therefore, Zofran® (ondansetron) may be prescribed as supportive care. Although, Zofran® is

commonly not recommended due to high cost, for PEP therapy the benefits of treating the nausea and vomiting

outweigh the risks of incurring additional cost during the preventative treatment.

When managing pharmacy benefits for HIV PEP, it is necessary to monitor not only utilization, but also cost,

particularly of the three most prevalently prescribed drugs: Truvada®, Isentress® and Tivicay®. Our analysis showed

that the price of all three drugs increased 37% to 41% over the last five years as a result of consistent annual

increases of 6.5% to 7.1%. It is also expected that Truvada® will be the first of these three drugs to go generic and

become available on September 30, 2020.14

Truvada®

Tivicay®

Isentress®

$3,000

$2,525

$2,050

$1,575

$1,100

October 13 March 15 August 16 January 1 June 19

Figure 1: Five-year Price Increases for Top Three HIV Drugs

9

WHEN MANAGING PATIENT OUTCOMES, THERE ARE SEVERAL IMPORTANT FACTORS THAT SHOULD BE CONSIDERED:

Although HIV infection is no longer considered a terminal disease and can be effectively managed with medication therapy,

there is no cure. If the injured worker contracts HIV, medications must be continued indefinitely, and therefore, present a

substantial lifetime treatment cost. For this reason, PEP can be seen as a highly cost-effective intervention. Current cost of the

four-week treatment ranges from $3,998.76 to $4,198.07, preventing an estimated lifetime cost of $379,668 according to the

CDC in 2010.15

continued HIV Antiretrovirals

Occupational exposure to HIV should be prioritized as an urgent medical concern and treated immediately

PEP medications should be started as soon as possible, but within 72 hours; If more than 72 hours have passed, PEP therapy should be considered upon expert consultation

PEP should be continued for four weeks and only discontinued if the source patient is tested and determined to be HIV negative

Because of the potential for intolerable side effects, some patients may have problems completing the four-week course

10

“...the optimal number of medications needed

for HIV PEP remains unknown.”

11

HEPATITIS CANTIVIRALS

Hepatitis C virus (HCV) is a blood-borne virus that

infects the liver. If left untreated, an acute infection may

spontaneously clear or become chronic and progress

to eventual liver failure and death. A person may

become infected through contact with infected blood.

The disease is quite common in the US as there are 2.4

million people estimated to be living with hepatitis C

virus infection. The most common risk factor for HCV

infection in this population is injection drug use. In the

workers’ compensation population however, hepatitis

C is rare. Guidelines that address occupation exposure

to hepatitis focus on needlestick or sharps exposure

by health care personnel (HCP) in which recent data

estimates the risk of infection to be as low as 0.2%

following exposure by percutaneous injuries and 0%

for mucocutaneous exposures.16 However, although

the prevalence of hepatitis C is low within workers’

compensation, the costs of the specialty medications to

treat hepatitis are very high and therefore can have a

substantial impact on pharmacy spend.

For guidance on how to manage HCPs infected with

HCV, the guidelines by the American Association for

the Study of Liver Diseases (AASLD) and the Infectious

Diseases Society of America (IDSA) provide the most

up-to-date recommendations. Unlike HIV exposure,

in which medications for post-exposure prophylaxis

(PEP) are started immediately following a suspected

infection, guidelines for HCV do not recommend PEP.17 It

is recommended that regular HCV laboratory monitoring

be conducted for a minimum of six months and up to 12

months following exposure to determine spontaneous

clearance versus persistence of HCV infection. The six-

month period following HCV exposure is referred to as

the acute period. It is estimated that the infection has

a 20% to 50% chance of spontaneous resolution within

this period. Treatment may proceed if an infection has

not spontaneously cleared after six months of laboratory

monitoring.

The decision on which medications to use for treatment

depends on many factors, but fundamentally the

genotype or strain of the virus has to be determined

since certain strains do not respond to certain

medications. This section focuses on the medications

recommended by the AASLD/IDSA guidelines for

genotype 1, which is the most common HCV genotype

in the US and found in over 70% of all HCV infections.

There is also a further classification of genotype 1

into subtype 1a and 1b. Subtype 1b is considered a

more severe form. It is also important to determine if

the patient has cirrhosis (liver scaring) before therapy

is started. The presence of cirrhosis indicates more

advanced disease and requires a longer course of

therapy, 12 weeks versus eight weeks, but does not

call for different medications. Lastly, the choice of

medications also depends on whether the patient has

been treated previously for hepatitis C, since this may

affect which drugs the patient may or may not respond

to also.

For HCPs who have a confirmed HCV infection after six

months of laboratory monitoring and have not been

previously treated for HCV, the AASLD/IDSA guidelines

specifically recommend one of four medications

including Zepatier®, Mavyret®, Epclusa® and Harvoni®

(see Table 4). According to the AASLD/IDSA guidelines,

the four recommended regimens provide comparable

efficacy. Two of the four medications are generically

available including Epclusa® and Harvoni®. Zepatier®

appears to be the most cost-effective regimen at this

time, and Harvoni® is the most expensive.

12

Although very costly, these new medications for HCV are highly effective and provide a cure, unlike HIV in which there is

no cure. Since non-treatment can lead to dire consequence, which can include the need for a liver transplant, these high-

priced medications are considered a cost-effective intervention. Cirrhosis due to hepatitis is the leading indication for liver

transplantation in the U.S. and the average cost of a liver transplant is about $812,500.18 However, the potential for the

virus to spontaneously resolve means that some cases of HCV exposure will not require medication therapy at all.

Table 4. AASLD/IDSA Regimen Recommendations for Treatment Naive Patients with Genotype 1a and 1b HCV

Drug Cost of Regimen CommentsRegimen

Zepatier® (elbasvir/grazoprevir)

Mavyret® (glecaprevir/pibrentasvir)

Epclusa® (sofosbuvir/velpatasvir)

Harvoni® (sofosbuvir/ledipasvir)

1 tablet once daily for 12 weeks

3 tablets once daily for 8 – 12 weeks

1 tablet once daily for 12 weeks

1 tablet once daily for 8 – 12 weeks

Same regimen for type 1a or 1b with or without cirrhosis

Same regimen for type 1a or 1b; Course duration may be shorten to 8 weeks for patients without cirrhosis

Same regimen for type 1a or 1b with or without cirrhosis

Same regimen for type 1a or 1b; Course duration may be shorten to 8 months in patient without cirrhosis, are non-black, HIV uninfected and have virus levels under 6 million IU/ml

$26,208

$31,680 – $46,440

$89,712 ($28,800) generic

$75,600 – $113,400($43,200) generic

13

INFLAMMATORY CONDITIONSDMARDs

Disease modifying anti-rheumatic drugs (DMARDs) work by various mechanisms to slow the disease process and help

prevent further joint damage. These medications are approved for the management and treatment of rheumatoid

arthritis (RA), but could also be used for psoriasis, ulcerative colitis, Crohn’s disease and ankylosing spondylitis (AS).

Workers’ compensation compensability for DMARDs may be more commonly related to RA and AS.

RA is a chronic, progressive, inflammatory autoimmune disorder that symmetrically affects the joints, typically those in

the hand, feet, wrists, elbows, knees and ankles. This causes inflammation that results in swelling and pain around the

affected area.19

AS is a chronic arthritis that causes inflammation of the joints near the lower spine and pelvis, with inflammation at

the insertion sites of tendons or ligaments into the bone. It has a tendency to affect the sacroiliac joints and cause

spinal fusion. The result is an inflammation of backbone that may cause abnormal stiffening, immobility of the

affected joint and pain in the buttocks, lower back and legs.

An individual’s genetic predisposition is generally the cause for development of these conditions, rather than the

result of a work-related injury. Experience, however, has dictated that RA and AS claims have been accepted as

compensable.

14

In 2012, the American College of Rheumatology published an update to the 2008 guidelines. To prevent disease

progression, the update includes more aggressive recommendations for when to start, resume or switch DMARD

therapy.

Non-biologic traditional DMARDs such as methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and

minocycline continue to be the first line therapy recommended.20 These medications are generally oral medications

and are more cost effective than the newer biologic DMARDs.

The treatment and goal of therapy is individualized per patient, depending on response to therapy and tolerance of

medications. The ideal goal is complete remission of disease or at least slowing the rate of progression. Combination

DMARD therapy, including double or triple therapy, may be utilized to achieve treatment goals. Traditional DMARDs

may be prescribed together or with a biologic DMARD, however, two biologics should not be prescribed together,

because the risks outweigh the benefits.21

15

continued Inflammatory Conditions DMARDs

Tumor necrosis factor (TNF) is a pro-inflammatory cytokine that has antitumor and antiviral activities. The toxicity of TNF limits

its clinical use for oncological treatment. However, it was discovered that anti-TNF biologics are highly effective for autoimmune

conditions associated with inflammation and now are extensively utilized.

Tumor necrosis factor alpha-blockers (TNF-alpha) biologics are considered the first-line biological DMARDs and may be used

alone or in combination with methotrexate. These include Humira®, Cimzia®, Enbrel®, Simponi® and Remicade®. Remicade® must

be prescribed with methotrexate. Other biologic DMARDs, non-TNF agents, include Rituxan®, Orencia®, Actemra® and Kevzara®.

Reassessment of disease progression is completed every three months for traditional and anti-TNF DMARDs, and every six months

for non-TNF biologics. If disease has not slowed progression, another agent is added or therapy is switched. After two trials of

anti-TNF biologic, a non-TNF agent is recommended.22

The utilization patterns of myMatrixx prescribers are consistent with the guidelines. Enbrel®, Humira® and Cimzia® are the top

biologic DMARDs utilized. Humira® and Enbrel® are in the top three in the top 20 drugs by 2018 U.S. sales according to IQVIA’s

latest report; Humira® came in first grossing $13.68 billion. Our cost analysis showed that the price of all three drugs increased

56% to 78% over the last five years.

Figure 2: Initial TNF-alpha Inhibitors Annual Cost since 2013

$83,000

$78,000

$73,000

$68,000

$63,000

$58,000

$53,000

$48,000

$43,000

$38,000

$33,000

$28,000January 17 July 18 January 20 July 21 January 23

Cimzia®

Humira®

Enbrel®

16

Cimzia® appears to be most expensive for initiation of

treatment, given that the initial annual cost is composed

of the Cimzia® Starter Kit and maintenance annual cost.

However, following the initial year, Cimzia® is the most

cost effective with an annual maintenance cost of $62,315.

Switching between biologic therapies is only recommended

by guidelines if the medication is ineffective or intolerable.

Evidence from U.S. National Survey Data estimated the

national indirect costs of RA-related absenteeism were

$252 million annually. Individuals with RA have higher

probabilities of missing work and missing workdays than

those without RA.23 This indicates the need for early

interventions to slow down or stop the progression of the

disease and keep people with RA in the work force.

Cimzia® Starter Kit + Cimzia®

Humira® or Humira Pen®

Enbrel® or Enbrel® SureClick

74000 75000 76000 77000 78000

Cost

$74,506.44

$74,506.92

$77,893.79

TNF - Alpha Inhibitors

17

OSTEOARTHRITISVISCOSUPPLEMENTATION

Osteoarthritis (OA) is a common degenerative joint disease characterized by the breakdown in cartilage of an

affected joint that results in pain, inflammation and stiffness. Any joint may be susceptible, but degradation

presents more frequently in hands, lumbar and cervical spine, and weight-bearing joints of the knees, hips

and feet. OA may be caused when the cartilage between joints wears out due to an injury or repetitive

stress. However, some workers might be predisposed genetically, and work could potentially exacerbate the

presentation of osteoarthritis.

Such occupational fields that may be at an increased risk for development of OA due to higher physical labor

demand include construction, firefighting, fisheries, forestry, mining, agriculture and healthcare.24 OA does not

have a cure, but there are ways to ease pain and maintain mobility of the joints.

18

First-line pharmacologic therapy recommendations

include acetaminophen (Tylenol®), oral NSAIDs and

local analgesics.25,26 Local analgesics recommended are

capsaicin, methyl salicylate creams and topical NSAIDs

(e.g. Voltaren® gel) and oral NSAIDs recommended

include OTC formulations such as Motrin® and

Aleve®. Non-pharmacologic therapy recommended as

initial treatment options have included physical and

occupational therapy, therapeutic lifestyle changes,

exercise, tai chi and use of assistive devices, such as

braces and canes. If a patient fails OTC therapy and

therapeutic lifestyle changes, prescription therapy

may be considered. Stronger NSAIDs and Cymbalta®

(duloxetine) are available by prescription that could be

used to treat chronic pain.27

Remaining pharmacologic options include opioid

analgesic therapy and intra-articular injections, such

as corticosteroid injections and viscosupplementation.

However, since OA of the knee is the only approved

indication for viscosupplementation, it is important to

note that the remainder of this discussion pertains only

to this condition.

If conservative treatments are not effective, then intra-

articular injections, such as corticosteroid injections

and viscosupplementation, may be used. Cortisone

injections may relieve pain in the joint; however, a

limitation of three or four injections per year is set due

to the high potential for worsening joint damage over

time.28 Viscosupplementation consists of injections of

hyaluronic acid, a component normally found in the

joint fluid. This treatment option may offer pain relief

by providing some cushioning in the knee.

The 2013 American Academy of Orthopedic

Surgeons (AAOS) guidelines strongly recommended

against the use of hyaluronic acid injections

(viscosupplementation) for patients with knee arthritis,

given the lack of benefit shown in randomized trials.29

Even though guidelines recommend against the use

of these medications, the hyaluronic acid derivatives

in table 5 continue to be utilized by myMatrixx

prescribers in a constant utilization rate since 2013.

Hyaluronic Acid Derivatives

Table 5

Drug

Synvisc-One®

Hyalgan®

OrthoVisc®

Synvisc®

Supartz®

Monovisc®

Recommended Dose

Inject 48 mg once

Inject 20 mg once weekly




Inject 88 mg once

Number of Injectionsper Course

1

5

4

3

5

1

Cost of Course

$1,559.34

$1,140

$2,294.40

$1,559.34

$1,381.80

$1,710.73

19

Botox® is indicated for a variety of conditions — axillary hyperhidrosis, chronic migraine, bladder dysfunction, certain eye

disorders (e.g. strabismus, blepharospasm), cervical dystonia, spasticity and cosmetic purposes (e.g. wrinkle reduction).30

Although there are the many approved indications, only a few can be potentially related to workers’ compensation injuries.

These include chronic migraine headaches, limb spasticity associated with traumatic brain injury (TBI) or spinal cord injury

(SCI), cervical dystonia associated with trauma and neurogenic (overactive) bladder associated with SCI.

Migraines: Approved by the FDA as treatment for chronic migraines, Botox® injections are an effective treatment option in treating

migraines and tension type headaches. Chronic migraines are “attacks occurring 15 days or more monthly for at least 3 months, with

attacks lasting 4 hours or more.”

Table 6: Use and Cost of Botox® Therapy per Indication

BOTOX®

Condition Treated Recommended as First-Line Agent

Cost Per Injection First-Line Pharmacologic Options for Condition

Dosing & Frequency

Chronic Migraine

Upper Limb Spasticity

Lower Limb Spasticity

Cervical Dystonia

Neurogenic Bladder

Yes

Yes

Yes

Yes

No

$1,442.40

$1,442.40

$721.20

$1,442.40 – $2,163.60

$1,442.40

Max 155 units every 12 weeks



198 – 300 units every 8 weeks


Prophylaxis: BoNT-A, topiramate, amitriptyline, beta-blockers

Acute Treatment:• Mild to moderate: NSAIDs, combination product (acetaminophen, aspirin, caffeine)• Moderate to severe: triptans

Focal: BoNT-A, BoNT-B

Generalized: baclofen, tizanidine

BoNT-A

Oral anticholinergic agents (i.e. oxybutynin, tolterodine, solifenacin)

20

Calcitonin gene-related peptide (CGRP) inhibitors, the most recent novel migraine treatment to enter the market in 2018 for the

treatment of episodic and chronic migraines. Although CGRP inhibitors are not recognized as specialty medications, their high cost

compared to existing therapeutic alternatives demands an assessment.

The American Headache Society (AHS) released a consensus statement in December 2018 regarding the use of CGRP inhibitors in

treatment therapy, there is insufficient evidence at this time to provide an anti-CGRP treatment guideline for migraine therapy. ,

Due to the high monthly cost and insufficient evidence available regarding the use of anti-CGRP treatment in migraine therapy, the

potential benefits of therapy do not outweigh the therapy cost. Therefore, use of first-line oral treatment options are recommended

over anti-CGRP therapy.

ALTERNATIVE MIGRAINETREATMENTS

Aimovig® (erenumab)

Ajovy® (fremanezumab)

Emgality® (galcanezumab)

70 – 140 mg once monthly

225 mg once monthly

120 mg once monthly

$345.00 – $690.00

$690.00

$690.00

Table 7

Monthly Cost of Anti-CGRP Migraine Prophylaxis Treatment

Although CGRP inhibitors are not recognized as specialty

medications, their high cost compared to existing

therapeutic alternatives demands an assessment.

21

continued Alternative Migraine Treatments

Limb Spasticity: Initially indicated for upper limb (elbow, wrist, fingers) spasticity or stiffness, the FDA expanded the indications

of Botox® to include treatment of lower limb (ankle and toe flexors) spasticity in 2016. Limb spasticity is a condition that causes

stiffness and flexing of muscles, twitching of limbs or loss of limb movement control. Spasticity can be the result of damage to

the nervous system due to a TBI or SCI.

According to the Official Disability Guidelines (ODG), “multiple clinical trials suggest that botulinum toxin A may be useful in

the management of spasticity following a traumatic brain injury,” and is therefore recommended as a first-line treatment option.

Botox® has not yet proven an increase in functional ability and is not intended to replace existing physical therapy.

Cervical dystonia: Characterized by involuntary neck contractions, cervical dystonia results in abnormal movements and

awkward posture of the head and neck. Initially mild, symptoms may start as an invisible tremor of the head, followed by

involuntary head pulling, turning or jerking that may increase in frequency and strength over time.

Though it is not generally related to a workers’ compensation injury by ODG standards, BoNT-A treatment is a recommended

first-line therapy for cervical dystonia. This treatment has shown to improve posture, pain and disability. BoNT-B is also effective

in treating cervical dystonia, but is reserved as an alternative for patients who fail to get clinical benefit after using BoNT-A due

to its high antigenicity effects.

Neurogenic Bladder: Overactive bladder (OAB) is a syndrome of bladder dysfunction symptoms (e.g. urinary urgency with or

without incontinence, urinary frequency, nocturia, urinary incontinence) which may all lead to a reduction in quality of life. The

cause of this overactivity may be due to neurogenic detrusor overactivity stemming from an SCI or multiple sclerosis.

First-line pharmacologic therapies for detrusor hyperreflexia are oral anticholinergic agents and BoNT. For patients whose

symptoms are refractory to first-line oral therapy, the use of BoNT provides an effective alternative to more invasive and

aggressive treatments (e.g. sacral nerve stimulation, bladder augmentation cystoplasty).

Patients cannot receive treatment with Botox® if they have an infection at the target injection site, a urinary tract infection or

urinary retention. Prophylactic antibiotic therapy should be administered 1 to 3 days prior to treatment, on the day of treatment

and one to three days following treatment with Botox®.

Though it is not generally related to a workers’

compensation injury by ODG standards, BoNT-A treatment

is a recommended first-line therapy for cervical dystonia.

22

CHEMOTHERAPEUTIC AGENTS As cancer treatment medications meet all criteria for specialty classification as defined by the American Journal of Managed

Care, it is important to discuss its impact in patient care.

The National Institute for Occupational Safety and Health (NIOSH) estimates between 45,872 to 91,725 of new cancer cases

reported in the U.S. in 2012 were associated with past occupational exposure. This estimated range is an underestimate

and may change over time as further information regarding agents in the workplace and number of cancers in the U.S. is

determined.40

Employees exposed to radiation and toxic substances during employment may be eligible for compensation and medical

benefits through the Energy Employees Occupational Illness Compensation Program Act of 2000 (the Act/EEOICPA). This act

outlines compensation for employees (or survivors if the worker is deceased) who are employed through the Department

of Energy (DOE), its contractors or members at subcontracted facilities and had developed certain diseases as a result of

occupational exposure to certain materials or radiation.41

The Special Exposure Cohort (SEC) was established as a result of the Act/EEOICPA, and specifies qualifications that an employee

must meet in order to be deemed compensable as well as established classes of employees and work sites. In order to qualify

for compensation through the act, the employee must have at least one of the following cancer types, in addition to having

worked at an associated SEC site.42, 43

• Bile ducts

• Brain

• Breast (male and female)

• Colon

• Esophagus

Cancer Type

Primary Cancer of the:

Comment

• Gall bladder

• Liver (except cirrhosis or

hepatitis B)

• Ovary

• Pancreas

• Pharynx

• Salivary gland

• Small intestine

• Stomach

• Thyroid

• Urinary bladder

Disease onset was at least five years after initial exposure

Bone, renal

Leukemia (other than chronic)

Lung

Multiple myeloma, lymphomas (other than Hodgkin’s)

Disease onset was at least two years after initial exposure

Other than in-situ discovered during or after post-mortem examTable 8

The Special Exposure Cohort Compensability Qualifications

23

• Alabama

• Alaska

• Arizona

• Arkansas

• California

• Colorado

• Connecticut

• District of Columbia

• Florida

• Georgia

• Idaho

• Illinois

• Indiana

• Iowa

• Kansas

• Kentucky

• Louisiana

• Maine

• Maryland

• Massachusetts

• Michigan

• Minnesota

• Missouri

• Montana

• New Mexico

• Nebraska

• Nevada

• New Hampshire

• New York

• North Dakota

• Ohio

• Oklahoma

• Oregon

• Pennsylvania

• Rhode Island

• South Dakota

• Tennessee

• Texas

• Utah

• Vermont

• Virginia

• Washington

• Wisconsin

• Wyoming

Cancer presumption laws affecting firefighters and emergency medical service (EMS) workers have remained a controversial topic

due to the removal of traditional burden of proof that an injury, illness or disease is the result of an occupational injury. Prior studies,

including a multi-year study conducted by NIOSH and the U.S. Fire Administration, concluded that firefighters were among an

occupational field with an increased risk of cancer.44

Federal regulations, such as the Firefighter Cancer Registry Act (enacted July 2018) require the CDC and NIOSH to establish a registry

of firefighters in order to determine correlation between occupational exposure and cancer development. Additionally, the James

Zadroga 9/11 Health and Compensation Reauthorization Act of 2015 provides funding for first responders and survivors with health

complications resulting from terrorist attacks.45

Cancer presumption laws enacted by 33 states have extended workers’ compensation coverage to include firefighters who have

developed one or more cancer types due to occupational exposure. The language and specifications, however, vary from state to

state, regarding compensability of certain cancer types and compensation qualifications, as there is no current federal legislation

available for guidance.46 There are 10 additional states that have written legislation stating workers’ compensation benefits are

managed by the local jurisdiction or the respective Fire Commission, though in some states this does not guarantee state approval.47

Cancer presumption laws enacted by 33 states have extended

workers’ compensation coverage to include firefighters who have

developed one or more cancer types due to occupational exposure.

continued Chemotherapeutic Agents

24

As the amount of spending for specialty medications and treatment costs continue to climb, it is important to determine

whether the state legislations describe specific conditions for workers’ compensation coverage for cancer presumption. It may

be anticipated that as further research relating occupational exposure and cancer development emerge through laws such as the

Firefighter Cancer Registry Act, cancer presumption legislation may further develop and outline how affected workers may be

compensated for their condition.

The statute language and specificity regarding presumption varied. For example, language written in some states’ statutes are

not specific in terms of cancer types that are covered, whereas other state statutes specify certain cancers such as leukemia,

brain, bladder, non-Hodgkin lymphoma and gastrointestinal. Though legislation may vary, the coverage criteria for presumption

generally consider the following:

THOUGH LEGISLATION MAY VARY, THE COVERAGE CRITERIA FOR PRESUMPTION GENERALLY CONSIDER THE FOLLOWING:

Type of cancer

Type of occupation

Pre-claim or pre-employment physical exam

Employee’s current work status

Time frame of employment or onset of disease

Retroactivity

Disability

25

The use of DOACs are known to reduce the risk of CV events such as PEs, VTEs and

stroke. Therefore, it is important to ensure that these patients are being treated

effectively to prevent such events from occurring. Non-adherence to these medications

leads to poor outcomes and increase cost in healthcare expenditure. Although,

there are many unwanted side effects of taking DOACs, with clinical monitoring and

supervision, the likelihood of these adverse events are less likely.

Lack of adherence to HIV treatment regimen could be fatal. More than 1.1 million

people in the U.S. are living with HIV, and about one out of seven are unaware that

they are infected.48,49 This makes it crucial to ensure that if an injured worker comes into

contact with potential blood borne pathogens that he or she seeks medical attention

right away. By ensuring medication adherence, the risk of HIV becoming treatment

resistant is reduced. Without proper drug therapy, HIV can progress to AIDS, and

these patients can develop multiple infections from opportunistic microbes such as

cytomegalovirus, Kaposi’s sarcoma, jiroveci pneumonia, etc.50 According to the CDC,

the lifetime cost of HIV treatment is $379,668.51 There are multiple resources for injured

workers to learn more about HIV such as the CDC and AIDSinfo.

HCV infection is one of the most common chronic infections, affecting an estimated

170 million people worldwide, and is the leading cause of chronic liver disease. For

HCV, treatment care should include medical education, laboratory testing, imaging,

diet management and an individualized treatment regimen.52 Adherence is critical in

avoiding further liver damage with leads to cirrhosis and possible liver cancer. Cirrhosis

due to hepatitis is the leading indication for liver transplantation in the U.S. and the

average cost of a liver transplant is about $812,500.53

There are many factors that lead to medication non-compliance with biological

DMARDs. These include therapy-related factors such as tolerability, administration

and convenience, as well as patient related factors such as age, health literacy, social

support and patient beliefs. Unfortunately, with medication non-adherence, many

complications can arise, such as further joint damage, osteoporosis, carpal tunnel

syndrome and even heart and lung problems. This can result in cardiovascular events,

such as a stroke or heart attack. The current average cost of treatment after a severe

heart attack, including direct and indirect costs, is about $1 million dollars, according to

an article from the National Business Group on Health.54

RISK OF NONCOMPLIANCESEVERAL COMPLICATIONS CAN ARISE DUE TO INSUFFICIENT TREATMENT AND/OR NONCOMPLIANCE. THESE COMPLICATIONS COULD LEAD TO EXTRANEOUS COSTS THAT INSURERS MUST PAY, WHICH COULD POTENTIALLY BE MUCH MORE THAN STANDARD TREATMENT THERAPY.

ANTICOALGULANTS

BIOLOGIC DMARDS

HEPATITIS C ANTIVIRALS

HIV ANTIRETROVIRAL

26

CONCLUSION

Specialty drugs are the fastest growing medications in the pharmaceutical market and have a massive impact on

healthcare spending and professional involvement. These medications require in-depth patient counseling, clinical

monitoring, medication management and financial strategies in order to increase cost-effectiveness while ensuring

full patient compliance. Communication and collaboration between all stakeholders involved in the patients’ care may

ultimately lead to improved health outcomes while maintaining cost of therapy.

This paper discussed the highest utilized specialty drugs and conditions represented in the 2018 myMatrixx Drug Trend

Report. However, claims handlers may also encounter anomalies for rare disorders, such as hereditary angioedema, that

can present a significant cost impact.

Undoubtedly, our data shows that when specialty drugs are added to the injured worker’s regimen, the total cost of

treating that patient rises exponentially. We stratified our claimants in three spending categories, what was found

is that in the group of patients that utilized less than $50K per year total in drug spend attributed to specialty only

accounted for 5.6% of drug spend and 1.8% of total patients. In the second group, total annual drug spend exceeded

$50K but was less than $1M, we saw the percentage of specialty drug use approached almost 40%. Those who used

over $1M of medications annually were found to be using specialty drugs almost exclusively.

As managed care pharmacist we recognize the strategy that these pharmaceutical companies are using to market these

drugs and gain profit share, is similar to what the industry has done for traditional drugs in that innovators can almost

guarantee immediate competition. These competing companies often use the progenitor drug to formulate their own

replicator of the drug. Most of the money is spent copying other drugs in order to compete and market “copy-cat”

drugs, which presents us with the challenge of distinguishing between specialty medications in the same therapeutic

class. There is a bigger challenge with presenting a therapeutic alternative for specialty medications to physicians,

due to the manufacturers marketing specialty medications as exclusively effective for a specific patient population.

Although this culture and adversities exist and acceptance rate is lower than traditional medications, when clinical

interventions lead to a change in therapy for specialty medications, the impact is substantial. Our goal as the PBM is to

provide solutions that improve the injured worker’s health while promoting financial accountability for the prescribing

of specialty medications.

myMatrixx Total DrugCost 2019 % of Total Spend % of Total Patients

< $50K

$50K to $1M

> $1M

91.4%

8.2%

0.4%

5.6%

37.7%

100.0%

1.8%

29.8%

100.0%

99.9%

0.1%

< 0.1%

% of Spend that is Specialty Drugs

% of Patients on Specialty Drugs

Table 9

27

ABOUT MYMATRIXX myMatrixx is a full-service pharmacy benefit management company focused on the workers’ compensation market. By

combining advanced technology, clinical expertise and comprehensive reporting, myMatrixx simplifies the management of

claims. Our results-driven solutions deliver reduced costs for our clients and improve outcomes for their injured workers. For

more information, visit www.mymatrixx.com. For drug inquiries or clinical services, email [email protected] or contact

your Clinical Account Executive.

ACKNOWLEDGEMENTWe wish to thank Nancy Wood, Philadelphia College of Osteopathic Medicine (PCOM) PharmD Candidate 2019, for the research

and time devoted defining best practices according to the updated treatment guidelines. Daniela Nunez, University of South

Florida PharmD Candidate 2020, for your editorial expertise and contributions throughout. We would like to recognize Brandon

Dang, PCOM PharmD Candidate 2020, for the invaluable assistance and dedication for the completion of this white paper. We

sincerely appreciate your time at myMatrixx and wish all of you success and happiness in your pharmacy careers.

28

APPENDICES

APPENDICES A – SPECIALTY MEDICATIONS

Samsca®

Sandostatin® (octreotide acetate)Sandostatin LAR Depot®

Signifor® LARSignifor®

Somatuline Depot®

Somavert®

Supprelin LA®

Testopel®

TriptodurTM

XermeloTM

ENZYME DEFICIENCIESAdagen®

Aldurazyme®

BrineuraTM

Carbaglu®

CerdelgaTM

Cerezyme®

Cystadane®

Elaprase®

ElelysoTM

Fabrazyme®

GalafoldTM

KanumaTM

Kuvan®

LumizymeTM

MepseviiTM

Naglazyme®

NityrTM

Orfadin® (nitisinone)PalynziqTM

RavictiTM

RevcoviTM

StrensiqTM

Sucraid®

VimizimTM

VPRIVTMZavesca® (miglustat)

GROWTH DEFICIENCYGenotropin®

Humatrope®

Increlex®

Macrilen®

Norditropin®

Nutropin AQ®

Omnitrope®

Saizen®

Serostim®

Zomacton®

Zorbtive®

HEMOPHILIAAdvate®

AdynovateTM

Afstyla®

Alphanate®

Alphanine SD®

AlprolixTM

Bebulin®

Benefix®

Coagadex®

Corifact®

DDAVP® (desmopressin acetate) (oral/nasal forms are not specialty)EloctateTM

Feiba®

Fibryga®

Hemlibra®

Hemofil M®

Humate-P®

Idelvion®

Ixinity®

Jivi®

Koate®

Kogenate FS®

Kovaltry®

Mononine®

Novoeight®

Novoseven RT®

Nuwiq®

ObizurTM

Profilnine SD®

Rebinyn®

RecombinateTM

RiaSTAP®

RixubisTM

Stimate®

Tretten®

VonvendiTM

Wilate®

Xyntha®

HEPATITIS CEpclusa® (sofosbuvir/velpatasvir)Harvoni® (ledipasvir/sofosbuvir)MavyretTM

Ribavirin (Rebetol®, Ribasphere®, Ribapak®, ModeribaTM)Sovaldi®

Viekira Pak®

Vosevi®

Zepatier®

HEREDITARY ANGIOEDEMABerinert®

Cinryze®

Firazyr® (icatibant)Haegarda®

Kalbitor®

Ruconest®

TakhzyroTM

HIGH BLOOD CHOLESTEROLJuxtapid®

HIVAptivus®*Atripla®*Biktarvy®

CimduoTM

Combivir®* (lamivudine/zidovudine)Complera®*Crixivan®*DelstrigoTM*Descovy®*Dovato®

Edurant®*Emtriva®*Epivir®* (lamivudine)Epzicom®* (abacavir/lamivudine)EvotazTM *Fuzeon®*Genvoya®*Intelence®*Invirase®*Isentress®*Juluca®

Kaletra®* (lopinavir/ritonavir)Lexiva®* (fosamprenavir)Norvir®* (ritonavir)

Odefsey®*PifeltroTM*PrezcobixTM*Prezista®*Rescriptor®*Retrovir®* (zidovudine)Reyataz®* (atazanavir)Sustiva®* (efavirenz)Selzentry®*Stribild®*SymFiTM

SymFi LoTM

SymtuzaTM

Tivicay®*Triumeq®*Trizivir®* (abacavir/lamivudine/zidovudine)TrogarzoTM

Truvada®*Tybost®*Videx®* (didanosine)Videx EC®* (didanosine DR)Viracept®*Viramune®* (nevirapine)Viramune XR®* (nevirapine ER)Viread®* (tenofovir disoproxil fumarate)Vitekta®*Zerit®* (stavudine)Ziagen®* (abacavir)

IDIOPATHIC PULMONARY FIBROSISEsbrietTM

OFEV®

IMMUNE DEFICIENCYBivigamTM

Cutaquig®

CuvitruTM

Cytogam®

Flebogamma®

Gamastan S-D®

Gammagard Liquid®

Gammagard S-D®

GammakedTM

Gammaplex®

Gamunex-C®

HizentraTM

HyQviaTM

Octagam®

Panzyga®

Privigen®

INFERTILITY(oral forms are not specialty)Bravelle®

Cetrotide®

Chorionic Gonadatropin (brands includeNovarel®, Pregnyl®)Crinone®

Endometrin®

Follistim AQ®

Ganirelix (ganirelix acetate)Gonal-F®

leuprolideMenopur®

Ovidrel®

progesterone injection

29

INFLAMMATORY CONDITIONSActemra®

Arcalyst®

Benlysta®

Cimzia®

CosentyxTM

Enbrel®

EntyvioTM

Humira®

Humira®(Pediatric)Ilaris®

IlumyaTM

InflectraTM

Kevzara®

Kineret®

Olumiant®

Orencia®

Otezla®

Remicade®

RenflexisTM

RinvoqTM

SiliqTM

SimponiTM

Simponi Aria®

SkyriziTM

StelaraTM

Taltz®

TremfyaTM

Xeljanz®

Xeljanz XR®

IRON TOXICITYExjade® (deferasirox)Ferriprox®

JadenuTM

MISCELLANEOUS DISEASESActhar H.P. Gel®

Actimmune®

Apokyn®

Arestin®

Arikayce®

Austedo®

Botox®

Botox Cosmetic®

CeprotinTM

Chenodal®

Cholbam®

Cystagon®

Daraprim®

Diacomit®

DuopaTM

Dysport®

EndariTM

Epidiolex®

Gamifant®

Gattex®

GocovriTM

HemangeolTM

HetliozTM

InbrijaTM

IngrezzaTM

JynarqueTM

Keveyis®

Krystexxa®

MakenaTM (hydroxyprogesterone caproate)Myobloc®

NortheraTM

NourianzTM

NuplazidTM

OcalivaTM

OnpattroTM

Prialt®

ProcysbiTM

Probuphine®

ProthelialTM

Qutenza®

Sabril® (vigabatrin)SinuvaTM

Solesta®

Soliris®

Sprix®

SpravatoTM

SublocadeTM

TegsediTM

Thiola®

Thyrogen®

UltomirisTM

Varithena®

VigadroneTM

Vivitrol®

VyleesiTM

VyndamaxTM

Vyndaqel®

Wakix®

Xenazine® (tetrabenazine)Xeomin®

XiaflexTM

XuridenTM

Xyrem®2Zecuity®

ZulressoTM

MULTIPLE SCLEROSISAmpyra® (dalfampridine)Aubagio®

Avonex®

Betaseron®

Copaxone® (glatiramer, Glatopa®)Extavia®

Gilenya®

Lemtrada®

Mavenclad®

Mayzent®

mitoxantrone®

Ocrevus®

Plegridy®

Rebif®

Tecfidera®

Tysabri®

MUSCULAR DYSTROPHIESEmflazaTM

Exondys 51TM

Firdapse®

RadicavaTM

Ruzurgi®

SpinrazaTM

Zolgensma®

OPHTHALMIC CONDITIONSCystaranTM

Eylea®

IluvienTM

Jetrea®

Lucentis®

LuxturnaTM

Macugen®

OxervateTM

OzurdexTM

Retisert®

Visudyne®

YutiqTM

OSTEOARTHRITISDurolane®

Euflexxa®

Gel-One®

Gelsyn-3TM

Genvisc 850®

Hyalgan®

Hymovis®

Monovisc®

Orthovisc®

Sodium hyaluronateSupartz FX®

Synvisc®

Synvisc-One®

Visco-3TM

ZilrettaTM

OSTEOPOROSISBoniva® (ibandronate) (oral forms are not specialty)EvenityTM

Forteo®

ProliaTM

Reclast® (zoledronic acid)TymlosTM

PULMONARY HYPERTENSIONAdcirca® (tadalafil)Adempas®

Flolan® (epoprostenol)Flolan Diluent® (epoprostenol diluent)Letairis® (ambrisentan)Opsumit®

OrenitramTM

Remodulin® (treprostinil)Remodulin Diluent®

Revatio® (sildenafil citrate)Tracleer® (bosentan)Tyvaso®

Uptravi®

Veletri®

Ventavis®

RESPIRATORY SYNCYTIAL VIRUSSynagis®

TRANSPLANTazathioprine (AZASAN, IMURAN)Astagraf XLTM*Cellcept®* (mycophenolate mofetil)Neoral®, Sandimmune®* (cyclosporine, Gengraf®)Envarsus® XR*Myfortic®* (mycophenolic acid)Nulojix®*Prograf®* (tacrolimus)Rapamune®* (sirolimus)Simulect®*Thymoglobulin®*Zortress®*

continued APPENDICES A – SPECIALTY MEDICATIONS

30

abicipar pegolabrocitinibbeta beglogene darolentivecentinostatfenfluraminefilgotinibidecabtagene vicleucel

APPENDICES B – PIPELINE

inebilizumab lisocabtagene maraleucel obeticholic acidozanimodpemigatinibponesimodquizartinib

ripretinib risdiplam satralizumab selumetinib valoctocogene roxaparvovecviltolarsen

Biosimilar

bevacizumab biosimilar

filgrastim biosimilar

pegfilgrastim biosimilar (Lapelga)

filgrastim biosimilar (Grastofil)

filgrastim biosimilar

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

1.

2.

3.

4.

5.

Biosimilar

etanercept-szzs (Erelzi)

adalimumab-atto (Amjevita)

adalimumab-adbm (Cyltezo)

infliximab-qbtx (lxifi)

adalimumab-adaz (Hyrimoz)

trastuzumab-pkrb (Herzuma)

trastuzumab-dttb (Ontruzant)

trastuzumab-gyyp (Trazimera)

etanercept-ykro (Eticovo)

adalimumab-bwwd (Hadilma)

adalimumab-afzb (Abrilada)

infliximab-axxq (Avsola)

Manufacturer(s)

Sandoz

Amgen

Boehringer Ingelheim

Pfizer

Sandoz

Celltrion/Teva

Merck/Samsung Bioepis

Pfizer

Merck/Samsung Bioepis

Biogen/Samsung Bioepis

Pfizer

Amgen

Reference Biologic

Enbrel (etanercept)

Humira (adalimumab)

Humira (adalimumab)

Remicade (infliximab)

Humira (adalimumab)

Herceptin (trastuzumab)



Enbrel (etanercept)

Humira (adalimumab)

Humira (adalimumab)

Remicade (infliximab)

Approval Date

8.30.2016

9.23.2016

8.25.2017

12.13.2017

10.31.2018

12.17.2018

1.18.2019

3.11.2019

4.25.2019

7.23.2019

11.15.2019

12.6.2019

Potential Launch Date

TBD (2028/2029)

Settlement: 3.31.2023


No US Launch Plans


Feb. – Apr. 2020

Feb. – Apr. 2020

Feb. 15th, 2020

TBD (2028/2029)



TBD (2020)

Manufacturer(s)

Samsung Bioepis

Adello Biologic

Apotex/Intas

Apotex/Intas

Tanvex BioPharma

Reference Biologic

Avastin (bevacizumab)

Neupogen (filgrastrim)

Neulasta (pegfilgrastim)

Neupogen filgrasyim)

Neupogen filgrasyim)

Possible FDA Approval Date

9.19.2020

2020

2020

2020

2020

Potential Launch Date

TBD

TBD (FDA Approval)

TBD (FDA Approval)

TBD (FDA Approval)

TBD (2020)

Specialty Medications

Biosimilar

FDA – Approved Biosimilars Pending Launch

31

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cdc/20711

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workplace/healthcareworkers.html

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